Synergy's team provides expert consulting services to help clients plan, execute, and manage their regulatory strategy and pharmaceutical development. Whether you need expert assistance drafting and reviewing submissions or evaluating audit readiness, Synergy's experts will deliver optimal support. Staff training is the most important internal factor relating to a company's efficiency and success.
At Synergy, all of our instructors work in the pharmaceutical development and regulatory affairs industry, so they have faced the same obstacles that your staff members will and can provide the practical insight needed for regulatory success.
-CONSULTING
Regulatory Strategy
Submission Preparation (IND, CTA, NDA, CTD, DMF, MAA, etc.) Audit Readiness (GMP, GCP)
Promotional Materials Review
Job Descriptions
SOPs
-TRAINING
CTD/eCTD content and preparation
Regulatory strategy development
FDA meeting request, preparation, conduct & follow-up
EU meeting requests, preparation, conduct & follow-up
GCP audit preparation
GMP audit preparation
Annual GCP training
Annual GMP training
SOP development
Clinical monitoring
Clinical development (all phases)
Drug development
ANDA requirements
Regulatory leadership & development
Regulatory department management
Risk assessment and mitigation
Safety requirements
Clinical project management
Promotional materials compliance
Global regulatory agency meetings
Technical writing
